Vitamin D Supplementation in Psychiatric Illnesses

NCT ID: NCT01004354

Last Updated: 2017-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2010-06-30

Brief Summary

Children and adolescents with psychiatric illnesses who are treated with medications called second generation antipsychotic agents (SGA) often gain excessive weight during their treatment with these medications. This weight gain may result in the development of features of the metabolic syndrome or frank diabetes mellitus. There is no consensus on the best way to prevent these complications. The investigators' hypothesis is that daily vitamin D supplementation in these patients will result in decreased levels of the markers of metabolic syndrome with associated reduction in waist circumference.

Detailed Description

In this 8-week open label trial, we will enroll 10 subjects who fulfill the Inclusion Criteria.

Conditions

Obesity; Vitamin D Deficiency; Psychosis; Schizophrenia; Schizoaffective Disorder

Keywords

Psychiatric illnesses; Vitamin D deficiency; Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vitamin D

Group Type: EXPERIMENTAL

Ergocalciferols

Intervention Type: DRUG

2000 international units by mouth daily for 8 weeks.

Interventions

Ergocalciferols

2000 international units by mouth daily for 8 weeks.

Intervention Type: DRUG

Other Intervention Names

Drisdol

Eligibility Criteria

Inclusion Criteria

1. Males/females between the ages 10 through 18 years,

2. Subjects with Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV)[62] Axis 1 diagnosis who are on treatment with SGA. These conditions include schizophrenia, schizo-affective disorder, and psychosis,

3. Subjects who have gained 10% of their pre-drug body weight while receiving the following SGAs: risperidone, aripiprazole, clozapine, quetiapine and olanzapine. Subjects could be taking other psychotropic agents, but only one SGA,

4. All subjects will be able to take the prescribed vitamin D by mouth,

5. All subjects will have a 25-hydroxyvitamin D level of < 32 ng/mL,

6. All subjects must reside in an in-patient psychiatric facility.

Exclusion Criteria

1. Pregnant or lactating women,

2. Patients with mental retardation (intelligence quotient < 50),

3. Subjects with specific systemic diseases such as diabetes mellitus, liver and kidney diseases,

4. Subjects with known history of parathyroid disorder,

5. Subjects with acquired or congenital disorders of vitamin D metabolism,

6. Subjects on calcium and vitamin D replacement therapy, such as calcium carbonate, or ergocalciferol, or cholecalciferol,

7. Subjects taking any weight loss medications, such as orlistat, and sibutramine,

8. Subjects on medications that might affect glucose levels, such as insulin or metformin.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Benjamin U. Nwosu

Study Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benjamin U Nwosu, MD

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts, Worcester

Locations

University of Massachusetts Medical School

Worcester, Massachusetts, United States

Countries

United States

Other Identifiers

Docket #13212

Identifier Type: -

Identifier Source: org_study_id